DrugPatentWatch Library

also from thinkBiotech:

Building Biotechnology: Starting, Managing, and Understanding Biotechnology Companies

From Test Tube to Patient
One of the FDA's most popular publications, From Test Tube to Patient tells the story of new drug development in the United States and highlights the consumer protection role of the Center for Drug Evaluation and Research.

Generic Drug Entry Prior to Patent Expiration
This Federal Trade Commission Study examined enforcement of antitrust laws in the pharmceutical industry and the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. Based on data obtained through this study, changes to the 30-month stay and the 180-day exclusivity provisions were recommended.


The FDA's generic 'Final Rule'
Seeking to curb abuse of measures that protect pioneer drugs from generic competition, the FDA reformed the procedures required for generic product entry in June 2003. This article from Modern Drug Development effectively summarizes these changes and their implications.